Kornimate/medical-research-clean huggingface dataset:
pantoprazole 20/40 mg in the treatment of symptomatic reflux disease with focus on sleep disorders

Conditions: Sleep Disorders; Non-Erosive Reflux Disease; Gastroesophageal Reflux Disease

Summary: the aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with nerd (non-erosive reflux disease) or egerd (erosive gastroesophageal reflux disease). the prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. the study was expected to provide further data on safety and tolerability of pantoprazole.


Eligibility criteria:
main inclusion criteria: * outpatients with erosive gastro-esophageal reflux disease (egerd) or non-erosive reflux disease (nerd) main exclusion criteria: * criteria as defined in the respective summary of product characteristics (chapter 4.3)

Keywords: ppi therapy pantoprazole egerd (erosive gastroesophageal reflux disease) nerd (non-erosive reflux disease)
inclisiran (leqvio®) in patients with atherosclerotic vascular disease and/or heterozygous familial hypercholesterolemia treated in spain: the inspire study

Conditions: Atherosclerotic Vascular Disease; Heterozygous Familial Hypercholesterolemia

Summary: this study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in spain.

the objective of the study is to determine the proportion of atherosclerotic cardiovascular disease (ascvd) and/or heterozygous familial hypercholesterolemia (hefh) patients reaching low-density lipoprotein-cholesterol (ldl-c) goals according to their cardiovascular risk at 12 months after the initiation of inclisiran treatment. the study also aims to evaluate changes in ldl-c levels, safety profile, adherence and persistence to inclisiran treatment, use of concomitant lipid-lowering therapy (llt), and patient satisfaction with inclisiran among other variables collected in clinical practice. this is a non-interventional, prospective, multicentric, and nationwide study that will be conducted in routine clinical practice in spain. this study will consist of three visits, coinciding with those conducted as part of the patients' routine follow-up, without interfering with the clinical practice of the participating centers. a blood test to assess ldl-c levels will be conducted at 3, 6, 9 and 12 months after inclisiran initiation, according to clinical practice.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years. 2. written signed informed consent form (icf). 3. patients with a confirmed clinical indication for inclisiran who have received the first dose of inclisiran, following clinical judgement, at least 2 months prior to the inclusion in the study. 4. available assessment of ldl-c levels (mg/dl) within 6 months before inclisiran initiation. the measurement of ldl-c levels must be done after one month of stable llt and without any modification from the testing up to inclisiran initiation. 5. statin-intolerant patients are eligible if they had documented side effects on ≥2 statins, including one at the lowest dose. exclusion criteria: 1. participating in a clinical trial of a treatment that could modify ldl-c levels during the observational period of the study.

Keywords: inclisiran leqvio® atherosclerotic vascular disease heterozygous familial hypercholesterolemia spanish clinical practice spain inspire ldl-c goal attaiment
evaluation of two resin composites and two adhesives for a novel restorative protocol to treat cervical lesions

Conditions: Dental Abrasion; Gingival Recession; Composite Resins

Summary: non-carious cervical lesion is frequently associated with gingival recession, resulting in a combined lesion that has a different treatment prognosis when the two lesions appear alone. the literature presents few studies that propose a multidisciplinary approach (restorative and root coverage surgery procedures) to optimize the treatment of this combined lesion. the previously proposed approaches and materials have limitations and an optimal clinical protocol has not been established yet. thus the aim of this study is to evaluate a novel multidisciplinary protocol with two resin composites and two different adhesive systems through a randomized clinical trial and laboratory studies. 120 combined lesions will be randomly assigned to one of the following groups: np + te (n = 30) - partial restoration of cervical lesions with nanofilled composite and total-etch adhesive system and periodontal surgery for root coverage, np + ua (n = 30) - partial restoration of cervical lesions with nanofilled composite and self-etching adhesive system and periodontal surgery for root coverage, mh + te (n = 30) - partial restoration of cervical lesions with microhybrid composite and total-etch adhesive system and periodontal surgery for root coverage, mh + ua (n = 30) - partial restoration of cervical lesions with microhybrid composite and self-etching adhesive system and periodontal surgery for root coverage. restorations will be assessed using the usphs criteria after one week, six months and twelve months.


Eligibility criteria:
inclusion criteria: * individuals presenting one or more combined defect, i.e. a nccl classified as b+ (pini-prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with miller's class i or ii gingival recession in canines or premolars with pulp vitality; * healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion; * plaque index ≤ 20% (ainamo \& bay, 1975); * nccl cavo-surface margin without involvement of more than 50% of enamel; * in tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (resolution #196 october 1996 and the code of dental professional ethics - c.f.o. - 179/93). exclusion criteria: * nccl previously restored; * presence of caries; * patients with periodontitis; * patients with bruxism or teeth clenching; * patients with orthodontic treatment in progress; * pregnant patients or smokers; * patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, diabetes and others), which contraindicate the surgical procedure; previous periodontal surgery in the area of interest of the present study.
diurnal variation in rectal diameter

Conditions: Constipation

Summary: the purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.


Eligibility criteria:
constipated inclusion criteria: * children from 4 to 12 years with previously diagnosed simple constipation defined by rome iii criteria, which at inclusion is in maintenance therapy with peg + e and has been in treatment for at least 1 month. exclusion criteria: * children with known organic causes of constipation, including hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases. * children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives. healthy inclusion criteria: * children between 4 and 12 years of age. healthy exclusion criteria: * children with known organic causes of constipation, including hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases. * children receiving drugs known to affect bowel function during a 2 month period before initiation. * children with a previous history of constipation, fecal incontinence and / or urinary tract infections.

Keywords: constipation children healthy rectal diameter
assessment of the effects of synbiotic on gut microbiota composition in scholars with overweight

Conditions: Childhood Obesity; Childhood Overweight

Summary: this study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. this study aimed to evaluate the effect of consuming fermented milk products containing lactobacillus casei strain shirota (lcs), as a probiotic enriched with prebiotic fructans from a. salmiana or inulin-like standard commercial prebiotic to improve the gut microbiota modulation. after providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. children were eligible for inclusion in the trial if they were overweight according to the world health organization (≥85th body mass index (bmi) percentile for overweight). the trial took place in three full-time elementary schools in san luis potosí, méxico, and the screening of the prospective participants took place up to 1 week prior to the randomization. children were evaluated over a 6-week intervention period receiving different fermented milk products

male and female children between the ages of 6- 10 years old were recruited from three schools located in san luis potosi, mexico. according to the world health organization, children with overweight were requested to participate and were voluntarily recruited. after providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. the trial investigated the effect of daily intake of fermented milk products containing lactobacillus casei strain shirota (lcs), lcs plus inulin (lcs+inulin), and lcs plus fructans from a. salmiana (lcs+fructans) on gut microbiota composition. the trial protocol was conducted according to the principles of the declaration of helsinki. it was approved by the ethical committee on human experimentation of the state committee of health education and research of the health secretary in san luis potosi (register number slp/012-2017).

Eligibility criteria:
inclusion criteria: * children were overweight or obese, according to the world health organization (≥85th body mass index (bmi) percentile for overweight, and ≥95th bmi percentile for obesity). exclusion criteria: * any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.

Keywords: microbiota probiotic fermented milk product synbiotic
effect of holly mangrove shower gel in atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a chronic intermittent inflammatory skin disease. currently, there are many cosmeceutical skin products in which their major action affects skin hydration and skin barrier function. in addition, there are some herbal medication remedies used for the treatment of skin diseases based on the knowledge of thai traditional medicine. patients with pruritic rash symptoms who attended the center of applied thai traditional medicine, siriraj hospital, were prescribed the holly mangrove shower gel to use and on the follow-up appointment showed significant improvement. nevertheless, the knowledge of using this herbal medication for treating pruritic skin rash so far has been categorized as folk wisdom and not been confirmed by any clinical-trial study on its efficacy and mechanism of action. research teams chose holly mangrove shower gel containing acanthus ebracteatus vahl to act as adjunctive for treating atopic dermatitis. thus, for the purpose of studying the efficacy of holly mangrove shower gel containing acanthus ebracteatus vahl in improving the skin barrier function in atopic dermatitis.

the investigators team research with patients by separate patients into 2 groups and compare among each other. in the first group use placebo, the other group use holly mangrove shower gel. to compare outcomes, the investigators will measure transepidermal water loss, stratum corneum hydration, skin ph, sebum and wrinkles after using studied gel.

Eligibility criteria:
inclusion criteria: * age 18 years old or above * diagnosed as atopic dermatitis (hanafin and rajka criteria) * no active dermatitis within 2 weeks exclusion criteria: * pregnancy or lactation * any other skin diseases on forearms

Keywords: atopic dermatitis skin barrier function transepidermal water loss skin ph stratum corneum hydration sebum wrinkle
cobiprostone for the prevention of oral mucositis in subjects with head and neck cancer receiving concurrent radiation and chemotherapy

Conditions: Oral Mucositis

Summary: treatment for head and neck cancer often involves a combination of chemotherapy and radiation. one of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis. this study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (rt/ct) standard care.


Eligibility criteria:
inclusion criteria: * recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality. * clinical treatment plan calls for a minimum of 50 gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (imrt) and/or image-guided radiation therapy (igrt), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen. exclusion criteria: * subject has received prior radiation to the head and neck region (+/- chemotherapy). * subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years. * subject has metastatic disease (m1) stage iv-c. * subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure. * subject is using a pre-existing feeding tube for nutritional support at study entry.
registry of diabetes patients in a large health maintenance organization in israel

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: a computerized registry of diabetes patients in a large health maintenance organization in israel. the registry is aimed to be used by health professionals to identify diabetes patients and to follow the courses of their illnesses and risk factors.

the registry was initiated in 1998 by maccabi healthcare services, which is the second largest publicly funded hmo in israel,serving 24% of the total population with a nationwide distribution. the registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Eligibility criteria:
inclusion criteria: diabetic patient was defined according to the criteria suggested by american diabetes association - symptoms diagnosed as diabetes and fasting plasma glucose \>125 mg/dl (7.0 lmol/l) or casual (namely, any time of day without regard to time since last meal) plasma glucose concentration p200 mg/dl. in order to reach maximal validity, we also included any patient who answered to one of the following: (1) purchased at least two hypoglycemic medications or single insulin dose during 6 months. (2) had hba1c result of at least 7.25%. hba1c of 6.5% was used as entry criterion to registry only when the patient was diagnosed as diabetic.

Keywords: registry,diabetes,health maintenance organization
management of pancreatitis: the role of supportive and drainage treatment

Conditions: Pancreatitis

Summary: this study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (msap) and severe acute pancreatitis (sap). the management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.

despite overall reduced mortality in the last decade, msap and sap are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. the management of sap is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). however, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. however, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. the applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of sap and its complications.

Eligibility criteria:
inclusion criteria: 1. fluid collections within two weeks of disease onset; 2. single- or multi-organ failure; 3. ctsi \> = 7 (initial ct performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (apache) ii score \> = 8. exclusion criteria: 1. patients without apd interventions; 2. patients who underwent necrosectomy directly after apd without pcd as a bridge therapy; 3. previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis; 4. previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of ap.

Keywords: necrotizing pancreatitis sepsis infection drainage
phenotypes in non ambulant duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Natural History; Motor Function; Retardation

Summary: the aims of the study are to prospectively collect information on several aspects of function in non-ambulant dmd patients by using a structured battery of tests including motor, respiratory and cardiac function

the aims of the study are to prospectively collect information on several aspects of function in non-ambulant dmd patients by using a structured battery of tests including motor, respiratory and cardiac function, to retrospectively review similar information on the data collected in the last decade and to establish the effect of steroids after loss of ambulation on different aspects of function. we also aim to use this integrated approach to identify patterns of severity and progression, the most appropriate outcome measures and endpoints in each group and possible genotype/phenotype correlations.

Eligibility criteria:
inclusion criteria: * children with genetically confirmed diagnosis of duchenne muscular dystrophy will be included in the study. we will include all duchenne muscular dystrophy boys who have lost the ability to walk independently. * all patients in whom consent can be obtained will be enrolled with no exclusion criteria. exclusion criteria: * patients lacking genetic confirmation of duchenne muscular dystrophy * patients still able to walk for more than 10 meters.
kettlebell swings & low back pressure pain threshold

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether a high intensity kettlebell workout, utilizing a tabata protocol format, can decrease objective measures of pain pressure threshold in subjects without low back pain. the results of the study could have implications for the use of high intensity kettlebell workouts in the rehabilitation of patients with low back pain.

the kettlebell swing is a full body, posterior-chain focused, ballistic exercise shown to register large recruitment of the gluteal muscles, which are frequently weak in a patients suffering from low back pain. the tabata protocol is a high-intensity training protocol in which subjects perform 20 seconds of all out effort (i.e. as many swings as possible), followed by 10 seconds of rest, repeated for a total of eight rounds. the rapid contraction-relaxation cycles utilized in the kettlebell swing are theorized to aid in the pumping out of muscle metabolites in the low back musculature, thus providing potential relief of chronic low back pain.

Eligibility criteria:
inclusion criteria: * those subjects between the ages of 18 and 45 * no current low back pain or pre-existing injuries that may be currently affecting them * no positive response on the health history questionnaire and par-q. exclusion criteria: * current low back pain * pre-existing injuries currently affecting the subject * positive response on the health history questionnaire or par-q * we will also be excluding minors and prisoners from this study.

Keywords: high-intensity